CloSYS

Manufacturer
Rowpar Pharmaceuticals, Inc. | Geodis Logistics LLC
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:27:09

Label at a glance#

ProductCloSYS
Active ingredientHydrogen Peroxide
Label structure9 sections

Indications and uses

For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Assist in the removal of foreign material from minor oral wounds.

Dosage and administration

Adults and children 12 years of age and older Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician Children 6 years to under 12 years of age: supervise use Children under 6 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrogen Peroxide 1.5% (w/v)

Purpose

OTC - PURPOSE SECTION

Oral debriding agent
Oral wound cleanser

Uses

INDICATIONS & USAGE SECTION

  • For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
  • Assist in the removal of foreign material from minor oral wounds.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use this product for more than 7 days unless directed by a dentist, or physician.

When using this product, do not swallow.

Stop use and ask a doctor if

  • sore mouth symptoms do not improve within 7 days.
  • irritation, pain or redness persists or worsens.
  • swelling, rash or fever develops.

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older

  • Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out
  • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician

Children 6 years to under 12 years of age: supervise use

Children under 6 years of age: do not use

Other Information

OTHER SAFETY INFORMATION

  • Do not use if safety seal is broken or missing
  • Cap tightly
  • Keep away from direct sunlight
  • Store at room temperature, 68 to 77°F (20 to 25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-643-3337

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS®
Oral Debriding Agent

MOUTH
SORES


SENSITIVE
MOUTH RINSE

PROMOTES HEALING

HELPS CLEANSE & PROMOTE HEALING OF
ORAL SORES, MOUTH BURNS & IRRITATION

For Canker Sores, Cheek Bites,
Irritation from Dentures or Braces,
Gum Irritation

Non Burning, Alcohol-Free
Formula

Gentle Mint

16 fl oz (473mL)

52516-75

Front Label
Front Label

Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807
1 (800) 643-3337 closys.com

52516-76

Back Label
Back Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
358975hydrogen peroxide 1.5 % MouthwashPSN2
358975hydrogen peroxide 15 MG/ML MouthwashSCD2
358975hydrogen peroxide 1.5 % MouthwashSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130647692000125GTIN-13: 0647692000125
EAN-13: 0647692000125
GTIN-12: 647692000125
UPC-A: 647692000125
GTIN storage (14 digits): 00647692000125
back-label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58578-0613-1CloSYS473 mL in 1 BOTTLERINSE4732
58578-0613-5CloSYS473 mL in 1 BOTTLERINSE4732
58578-0613-5CloSYS1 in 1 CARTONRINSE12
58578-0613-7CloSYS473 mL in 1 BOTTLERINSE4732
58578-0613-7CloSYS3 in 1 PACKAGERINSE32

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58578-061358578-0613-1, 58578-0613-5, 58578-0613-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSHYDROGEN PEROXIDERowpar Pharmaceuticals, Inc.299fc7b1-af6d-4bf9-810f-d35283423fe22025-12-17WarningsExact identifier
ndc (package): 58578-0613-5
ndc (package): 58578-0613-7
ndc (package): 58578-0613-1
ndc (product): 58578-0613
ndc11 (package): 58578061305
ndc11 (package): 58578061307
ndc11 (package): 58578061301
spl id: 2db642d7-8842-4aac-9deb-6cdbd4d9f955
spl set id: 299fc7b1-af6d-4bf9-810f-d35283423fe2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.